The global immunoassay market size was valued at USD 30.02 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 5.31% from 2023 to 2030. The market growth can be attributed to the increase in chronic and infectious diseases, including the outbreak of COVID-19. In addition, the rise in the geriatric population, which is more prone to chronic and infectious diseases, will aid growth. An increase in the prevalence of chronic conditions, such as cancer, infections, cardiovascular diseases, autoimmune diseases, diabetes mellitus, and nephrological diseases, has led to the wide usage of immunoassay techniques in disease diagnostics. The incidence of cancer is increasing steadily, which is expected to drive the demand for effective diagnostic methods such as immunoassay. This technique is significant in the determination of oncogenesis and diagnosis of cancer, such as benign or malignant, and its different stages. It facilitates the use of monoclonal and polyclonal antibodies to detect specific antigens in tissues by determining the presence of tumor antigens.
Applications of immunoassay-based diagnostics are significantly increasing globally. Public awareness campaigns aimed at identifying the symptoms of infectious diseases and ways to prevent them play an important role in controlling the epidemic disease. Thus, increased patient awareness has led to high demand for immunoassays. For instance, the advocacy program by the International Society for Infectious Diseases focuses on collaborating with clinicians, public health practitioners, and researchers globally and supporting the exchange of scientific knowledge and application of public health practices and evidence-based medicine. In addition, in 2018, the World Hepatitis Alliance launched the “Find the Missing Millions” campaign to raise awareness regarding hepatitis and remove barriers in clinical diagnostic settings.
Clinical interpretation of diagnostic tests is dependent on assay analyzers and the presence of a technical and skilled workforce. Results of assays are affected by the time taken for interpretation. Thus, technological advancements have led to an increase in the number of automated instruments and equipment used in laboratories. Automation has benefits such as higher efficiency and usage of less space and labor in laboratories. Thus, the market is witnessing lucrative growth as some market players are introducing automated laboratory systems and point-of-care compact, portable assay tests.
The use of antibodies in immunoassays is based on immune responses to the antigen of a particular microorganism. On the other hand, in molecular diagnostics, nucleic acid probes are based on specific genetic makeup. Thus, the adoption of molecular diagnostic tests is expected to increase over the forecast period, which may restrain the growth of the market for immunoassays.
The immunoassay product is crucial in controlling the spread of the coronavirus. In the lack of a vaccine or medication, the only efficient way to bound and limit the growth of illnesses and the potential number of casualties is to diagnose them. Rapid testing has proven to be an effective, quick, and easy molecular test for huge COVID-19 monitoring. SARS-CoV2 detection difficulties have been eased thanks to extensive research, appraisals, and authorizations of various immunoassay solutions and analyzers. Immunoassays like chemiluminescence, enzyme-linked, lateral flow-based point of treatment diagnostics, fast tests, and other techniques have seen an increase in their utilization.
The market has been affected by the market's demanding regulatory standards for immunoassay product approval and the technical challenges of immunoassay products and reagents. Due to the widespread diagnosis of COVID-19, the immunoassay industry in various countries has seen tremendous expansion throughout the epidemic. Moreover, as the number of COVID-19 cases rises in the third wave, the market is projected to rise even more.
Reagents and kits contributed to the largest market share of 66.1% in the immunoassay market for 2022. The segment is expected to maintain its lead over the forecast period. The large share can be attributed to the high demand for immunoassay reagents and kits for diagnosis purposes with the growing prevalence of infectious and autoimmune diseases. In addition, the approval and launch of novel immunoassay kits are expected to support the segment growth.
The software and services segment is anticipated to register a CAGR of 5.0% over the forecast period. This can be attributed to the increased availability and high demand for cost-effective immunoassay services in developing markets. For instance, in June 2020, Sysmex Corporation began providing novel coronavirus (SARS-CoV-2) antibody lab assay services.
Enzyme Immunoassays (EIA) held the largest market of 63.93 in 2022 by generating a revenue of USD 19,190.97 million owing to its repeated usage in the detection of infectious and chronic diseases, food allergies, and drugs of abuse among other applications. Some of the major advantages of this method over Immunoelectrophoresis and immunodiffusion are reduced assay time, quantitative results, and the requirement of limited antisera for analysis.
A rapid test, also known as lateral flow immunoassay, is used to detect the existence of the target analyte without utilizing specialized equipment. The rapid test technique has various applications such as in dengue and infections caused by Legionella, Salmonella, Campylobacter, Zika, and Listeria. Furthermore, monoclonal antibodies are used specifically for Immunoglobulin G (IgG), Immunoglobulin M (IgM), Immunoglobulin A (IgA), and Immunoglobulin (IgD) for precise identification of target analyte.
Based on application, the infectious diseases testing segment held the largest market share of 28.79% in 2022 and is anticipated to grow at the fastest rate over the forecast period. The segment is anticipated to maintain its lead over the forecast period. This high share can be attributed to the rise in the incidence of infectious diseases such as HIV, malaria, influenza, and the novel COVID-19. The launch of new products in the field of infectious disease testing is further driving the market.
The increasing prevalence of cancer cases globally is one of the major factors contributing to the growth of the market for immunoassays during the forecast period. According to a report published by the International Agency for Research on Cancer, the incidence of cancer was estimated to be 18.1 million new cases, whereas about 9.6 million deaths due to the disease were recorded in 2018. Thus, a rise in the incidence of cancer is anticipated to boost the adoption of immunoassays.
Based on end-use, hospitals segment dominated the overall market in terms of revenue in 2022 with 32.77% market share and is anticipated to maintain its dominance over the forecast period. The rise in the number of hospitals has led to the high growth of this segment. With the ongoing changes in the healthcare industry, the need for hospitals with advanced facilities has increased.
Blood banks are anticipated to witness growth during the forecast period owing to the rising number of infectious diseases being tested for in these laboratories during the screening and processing of donated blood. In addition, ELISA is simple to perform and requires minimal specialized instruments and equipment, hence is widely used in blood banks.
North America generated the highest revenue in immunoassay market with 39.45% share in 2022 and is anticipated to dominate the market throughout the study period. This can be attributed to the rising demand for diagnostics due to the increase in the incidence of cancer and the easy availability of technologically advanced diagnostic techniques. In addition, the high incidence of infectious diseases in the region, such as HIV, tuberculosis, and influenza, is boosting the demand for detection and treatment.
Asia Pacific region is projected to witness rapid growth with 6.81% CAGR over the forecast period as a result of increasing penetration of leading players in the region. In addition, the growing adoption of innovative laboratory techniques and procedures for faster investigation and diagnosis of infectious and chronic disorders is one of the factors driving the market in the region. Moreover, the introduction of molecular kits and the increase in demand for reagents used in diagnosis are key factors driving the market.
Key companies are undertaking extensive strategic initiatives in the field of immunoassays, including mergers and acquisitions, new product development, and regional expansion, to address the unmet needs of patients. For instance, in November 2020, Siemens Healthineers announced that its SARS-CoV-2 IgG Antibody Test has proven to measure neutralizing antibodies and has gained CE Marking. This test is an improved version of its previously launched COVID-19 antibody test. Additionally, in November 2018, bioMérieux acquired a majority stake in Suzhou Hybiome Biomedical Engineering Co. Ltd. This acquisition is expected to strengthen the company’s presence in the market in China.
Moreover, Abbott Laboratories focuses on chia technology and offers an automatic immunoassay analyzer named Abbott prism. It is quite effective for blood screening with practical results. Other advantages of these systems include cGMP compliance, error reduction due to the network's tampering resistance, increased lab productivity, and reduced human involvement because the system takes care of routine details including monitoring, processing, and documentation. Some prominent players in the global immunoassay market include
Siemens Healthineers
bioMérieux SA
Abbott Laboratories
Danaher Corporation (Beckman Coulter)
Quidel Corporation
Ortho Clinical Diagnostics
Sysmex Corporation
Bio-Rad Laboratories, Inc.
Becton, Dickinson, and Company
F. Hoffmann-La Roche AG
Thermo Fisher Scientific, Inc.
Report Attribute |
Report Details |
Market size value in 2023 |
USD 31.43 billion |
Revenue forecast in 2030 |
USD 45.1 billion |
Growth rate |
CAGR of 5.32% from 2022 to 2030 |
Base year for estimation |
2022 |
Historical data |
2019 - 2021 |
Forecast period |
2023 - 2030 |
Quantitative units |
Revenue in USD million/billion and CAGR from 2023 to 2030 |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Segments covered |
Product, specimen, technology, application, end-use, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
Country scope |
U.S.; Canada; U.K.; Germany; Spain; France; Italy; Russia; Japan; India; China; South Korea; Singapore; Australia; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE |
Key companies profiled |
Siemens Healthineers; bioMérieux SA; Abbott Laboratories; Danaher Corporation (Beckman Coulter); Quidel Corporation; Ortho Clinical Diagnostics; Sysmex Corporation; Bio-Rad Laboratories, Inc.; Becton, Dickinson and Company; F. Hoffmann-La Roche AG; Thermo Fisher Scientific, Inc. |
Customization scope |
Free report customization (equivalent to up to 8 analysts’ working days) with purchase. Addition or alteration to country, regional & segment scope |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global immunoassay market report on the basis of product, technology, application, end-use, and region:
Product Outlook (Revenue, USD Million, 2018 - 2030)
Reagents & Kits
ELISA Reagents & Kits
Rapid Test Reagents & Kits
ELISPOT Reagents & Kits
Western Blot Reagents & Kits
Other Reagents & Kits
Analyzers/Instruments
Open Ended Systems
Closed Ended Systems
Software & Services
Specimen Outlook (Revenue, USD Million, 2018 - 2030)
Blood
Saliva
Urine
Other Specimens
Technology Outlook (Revenue, USD Million, 2018 - 2030)
Radioimmunoassay (RIA)
Enzyme Immunoassays (EIA)Rapid Test
Chemiluminescence Immunoassays (CLIA)
Fluorescence Immunoassays (FIA)
Others
Application Outlook (Revenue, USD Million, 2018 - 2030)
Therapeutic Drug Monitoring
Oncology
Cardiology
Endocrinology
Infectious Disease Testing
Autoimmune Diseases
Others
End-use Outlook (Revenue, USD Million, 2018 - 2030)
Hospitals
Blood Banks
Clinical Laboratories
Pharmaceutical and Biotech Companies
Academic Research Centers
Others
Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
Germany
U.K.
France
Italy
Spain
Russia
Asia Pacific
Japan
China
India
Australia
South Korea
Singapore
Latin America
Brazil
Mexico
Argentina
MEA
South Africa
Saudi Arabia
UAE
b. The global immunoassay market size was estimated at USD 30.02 billion in 2022 and is expected to reach USD 31.43 billion in 2023.
b. The global immunoassay market is expected to grow at a compound annual growth rate of 5.31% from 2023 to 2030 to reach USD 45.15 billion by 2030.
b. North America dominated the immunoassay market with a share of 39.45% in 2022. Constant adoption of innovative techniques and the presence of developed healthcare infrastructure in the U.S. are factors fueling the immunoassay market in the U.S.
b. Some key players operating in the immunoassay market include Siemens Healthineers, Becton, Dickinson & Company, BioMérieux, Abbott laboratories, Roche Diagnostics, Danaher Corporation, Ortho-clinical diagnostics, Sysmex Corporation, Thermo Fisher Scientific, Inc., and Quidel Corporation.
b. Key factors that are driving the immunoassay market growth include an increase in chronic & infectious diseases globally, a rise in the geriatric population prone to such chronic and infectious diseases, and high demand for portable and automated immunoassays.
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With COVID-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for COVID-19 as a key market contributor.